Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain (MMPITR)

December 21, 2018 updated by: Kevin J Flynn MD

Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging

Adult patients with kidney stones undergoing surgical intervention with ureteroscopy with laser lithotripsy will be randomized to receive one of two different regimens of oral medications administered prior to induction of general anesthesia. Postoperatively, patients will receive automated daily text messages to assess pain and opioid consumption and subsequently determine which which treatment regimen is superior.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Adult patients undergoing ureteroscopy for kidney stones will be screened and those who meet initial study criteria (adult, English speaking, non-pregnant, non-intellectually disabled patients), will be sent an information letter outlining the study. Interested patients, who possess a phone capable of text messaging will be consented to enroll in the study and randomized to one of two preoperative analgesic treatment arms (see below) that will be administered in the preoperative area prior to induction of general anesthesia.

Multimodal Analgesia Arm

  1. Acetaminophen 975mg
  2. Gabapentin 800mg
  3. Oxycodone 10mg
  4. Celecoxib 400mg

Acetaminophen Only Analgesia Arm

a. Acetaminophen 975mg

Consenting patients will fill out a baseline demographics questionnaire as well as provide baseline levels of pain and opioid consumption prior to surgery. They will also be enrolled to receive automated postoperative pain assessments and opioid consumption inquiries via text message. The patients will be blinded to the treatment they are receiving. The research team will not be blinded. The patient will then proceed with their planned ureteroscopy. The patient will then undergo their planned ureteroscopy with lithotripsy for kidney stone disease; the study does not change any parameters about the surgery itself. The general anesthesia regimen will be standardized to one particular standard of care method so as to minimize the potential effect of confounders.

All patients (patients in both preoperative analgesia treatment regimen arms) will be monitored in the post-anesthesia recovery unit for pain, blood pressure, sedation level monitored by the Ramsey Sedation Scale. Once they have recovered appropriately and met standard discharge criteria they will be discharged with the following analgesic regimen

  1. Tylenol 650 every 6 hours x 7 day
  2. Oxybutynin 5mg three times daily as needed for x 7 days
  3. Flomax 0.4mg daily x 7 days
  4. Oxycodone, 5mg as needed 15 pills
  5. Celecoxib daily for 7 days

Patients will receive a pain assessment via text message the evening of postoperative day 0, and then twice a day for 14 days. Patients will also receive an opioid consumption inquiry once a day for 14 days. On postoperative day 15 patients will be asked if they were happy with their postoperative pain control.

During the study period the research team will access the patients electronic medical record to review and record the following information

  • Current medications
  • height, weight, age, gender, marital status, city, state of residence
  • Co-morbid medical conditions
  • insurance
  • stone parameters: size (mmm), location, laterality, number of stones,
  • Operative factors: instruments used, operative time, operative complications
  • post-operative course: emergency department visits, unexpected phone calls, unexpected clinic visits, other 30-day complications

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Patient (greater than 18 years old)
  • Possesses or has access to cell phone with text message capability
  • Undergoing ureteroscopy with lithotripsy for a ureteral or kidney stones

Exclusion Criteria:

  • Does not possess or have access to a cell phone with text message capability
  • Non-English speaking
  • Incarcerated individuals
  • undergoing planned secondary procedure
  • pregnancy
  • intellectual disability
  • History of, anaphylactic, rash, or other hypersensitivity reaction to any of the study agents
  • Patients with history of CABG, myocardial infarction, endovascular cardiac stent, gastrointestinal bleed, or gastric ulcer disease will not receive Celecoxib. They may still participate in the study otherwise, it will be documented that they did not receive an NSAID component.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodel Drug Regimen

The patients randomized to this arm will receive the following multimodal oral drug regimen administered shortly before induction of general anesthesia

  1. Tylenol, 975mg (3 tabs)
  2. 800mg Gabapentin
  3. 400mg Celecoxib
  4. 10mg Oxycodone
Drug: Multimodal Oral Drug Regimen
Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways
Other Names:
  • Gabapentin 800mg
  • Oxycodone 10mg
  • Acetaminophen 975mg
  • Celecoxib 400mg
Active Comparator: Acetaminophen Only

The patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia

1. Tylenol, 975mg (3 tabs)
Drug: Acetaminophen
Acetaminophen 975mg
Other Names:
  • Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative day 0 Pain
Time Frame: 4-6 hours after conclusion of surgery
The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes
4-6 hours after conclusion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to pain resolution
Time Frame: Approximately the first 72-96 hours
The amount of time (days) that it takes for patients to report a pain level of less than 4 (0-10 scale)
Approximately the first 72-96 hours
Opioid Consumption
Time Frame: 14 days following surgery
The number of total opioid pills a patient consumes following surgery
14 days following surgery
Time to complete pain resolution
Time Frame: 14 days
The amount of time (days) that it takes for patients to report a pain level of 0 (0-10 scale)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kevin J Flynn MD

Investigators

  • Principal Investigator: Chad Tracy, MD, University of Iowa Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201805826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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